PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients are randomized to one of two treatment arms.
Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients
remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral
clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110.
Following ovulation, treatment with clomiphene citrate and metformin or placebo continues
until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients
receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate
may be crossed over to receive metformin after a 6 week washout.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
William S. Evans
University of Virginia
United States: Federal Government
|Louisiana State University School of Medicine||New Orleans, Louisiana 70112-2822|
|Washington University - St. Louis||St. Louis, Missouri 63110|
|University of Virginia||Charlottesville, Virginia 22908|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Medical College of Virginia School of Medicine||Richmond, Virginia 23298-0230|